DSIP Capsules(Delta Pw tsaug zog Inducing Peptide Capsules, delta pw tsaug zog inducing peptide capsules) yog qhov ncauj formulations nrog DSIP (delta pw tsaug zog inducing peptide) ua cov khoom tseem ceeb, tsom rau kev txhim kho tib neeg kev noj qab haus huv los ntawm kev tswj kev pw tsaug zog, alleviating stress responses, thiab muaj peev xwm siv tshuaj kho mob. DSIP, raws li ib txwm tshwm sim tsis muaj peptide neuroregulatory tshuaj, tau dhau los ua kev tshawb fawb hotspot nyob rau hauv thaj chaw ntawm neuroscience thiab tshuaj txij li thaum nws nrhiav tau nyob rau hauv 1970s vim nws tshwj xeeb physiological teebmeem thiab dav daim ntawv thov prospects. Nws cov teebmeem physiological tseem ceeb, tab sis cov kev txhaj tshuaj ib txwm muaj teeb meem xws li kev siv tsis yooj yim thiab kev ua raws li tus neeg mob tsis zoo. Tsis tas li ntawd, qhov ncauj bioavailability ntawm DSIP yog qhov tsawg kawg nkaus, uas txwv nws daim ntawv thov hauv chaw kho mob thiab kev kho mob. Txoj kev loj hlob ntawm DSIP capsules lub hom phiaj txhawm rau txhim kho qhov nqus ntawm qhov ncauj ntawm DSIP los ntawm kev tsim tshuab, yog li muab txoj hauv kev yooj yim dua thiab nyab xeeb ntxiv rau DSIP.
Dsip COA
DSIP (Delta Pw tsaug zog Inducing Peptide) yog luv luv peptide uas muaj 9 amino acids, pib cais thiab muab rho tawm los ntawm luav hlwb homogenate, thiab tom qab ntawd pom tau dav faib nyob rau hauv nruab nrab paj hlwb thiab peripheral cov ntaub so ntswg ntawm cov tsiaj.DSIP capsules, raws li qhov ncauj formulations nrog DSIP raws li cov khoom tseem ceeb, lub hom phiaj los txhim kho tib neeg txoj kev noj qab haus huv los ntawm kev tswj kev pw tsaug zog, txo kev ntxhov siab, thiab kev siv tshuaj kho mob.
Chemical properties thiab physiological hauv paus ntawm DSIP
Molecular qauv thiab physicochemical zog
Cov mis mos molecular ntawm DSIP yog C35H48N10O15, nrog rau qhov hnyav molecular ntawm kwv yees li 849.8 g / mol. Cov amino acid sequence yog Trp Ala Gly Gly Asp Ala Ser Gly Glu. Nws cov qauv molecular sib txuas cov cheeb tsam hydrophilic thiab hydrophobic, muab nws lub peev xwm tshwj xeeb los nkag mus rau biofilms. DSIP yog qhov ruaj khov ntawm lub cev pH thiab tuaj yeem ua rau muaj zog enzymatic hydrolysis ntawm cov kua txiv pancreatic, tab sis nws qhov ncauj bioavailability tsawg heev (<1%), so traditional DSIP applications mainly rely on injection routes. The development of DSIP capsules aims to improve the oral absorption rate of DSIP through formulation technology improvements.
Natural tis thiab synthetic pathways
DSIP yog dav faib nyob rau hauv lub hypothalamus, pituitary caj pas, qog adrenal, thiab peripheral cov ntaub so ntswg xws li lub plab thiab hnyuv. Nws cov synthesis tuaj yeem koom nrog kev tswj hwm ntawm hypothalamic pituitary adrenal axis (HPA axis), tab sis qhov tshwj xeeb synthesis enzyme system thiab cov txheej txheem tswj hwm tsis tau ua tiav. DSIP nyob rau hauv DSIP capsules tej zaum yuav tau los ntawm cov tshuaj synthesis los yog bioengineering cov tswv yim los xyuas kom meej lawv purity thiab kev ua.
Ntshav-b hlwb barrier nkag mus
DSIP tuaj yeem nkag mus rau hauv cov ntshav tau zoo-b hlwb barrier (BBB), thiab kev sim tsiaj tau lees paub los ntawm cov ntawv xov tooj cua uas tau txhaj tshuaj DSIP tuaj yeem tshawb pom sai sai hauv cov ntaub so ntswg hauv hlwb, thiab nws cov concentration yog cuam tshuam nrog cov ntshav plasma. Cov yam ntxwv no ua rau nws yog ib qho ntawm ob peb exogenous peptide tshuaj uas tuaj yeem ua ncaj qha rau hauv nruab nrab paj hlwb. DSIP capsules yuav tsum tau tsim cov cuab yeej siv los tiv thaiv DSIP los ntawm plab hnyuv enzymatic hydrolysis thiab txhawb nws txoj kev nkag mus rau hauv plab hnyuv mucosa thiab ntshav- lub hlwb teeb meem, yog li ua rau lub hauv paus paj hlwb tswj cov teebmeem.
Formulation technology ntawm DSIP capsules
Txhawm rau txhim kho qhov ncauj bioavailability ntawmDSIP capsules, cov txheej txheem hauv qab no tuaj yeem siv tau:
Nanocarrier technology
qhwv DSIP nyob rau hauv nanoparticles (xws li liposomes thiab polymer nanoparticles) los tiv thaiv nws ntawm plab hnyuv enzymatic hydrolysis thiab txhawb nws txoj kev hla ntawm txoj hnyuv mucosa. Qhov loj me me ntawm nanoparticles feem ntau yog tswj los ntawm 100-200 nm txhawm rau txhim kho lawv cov kev faib khoom lom neeg thiab cov cellular uptake efficiency.
Micro ntsiav tshuaj technology
Ua DSIP rau hauv microspheres kom nce qhov chaw sib cuag ntawm cov tshuaj thiab cov hnyuv mucosa, thiab txhim kho kev nqus tau zoo. Qhov loj me me ntawm microspheres feem ntau yog tswj los ntawm 0.5-1.5 hli thiab tuaj yeem npaj los ntawm extrusion dov txoj kev lossis fluidized txaj txheej txheej.
Enteric txheej technology
Muab cov ntaub ntawv coated enteric (xws li hydroxypropyl methylcellulose phthalate thiab cellulose acetate phthalate) nyob ib ncig ntawm txheej txheej ntawm cov tshuaj ntsiav kom tso cov tshuaj hauv cov hnyuv thiab tiv thaiv kev puas tsuaj rau gastric acid. Lub thickness thiab muaj pes tsawg leeg ntawm enteric txheej yuav tsum tau optimized los xyuas kom meej cov tshuaj tso tawm ntawm tej pH qhov tseem ceeb.
Penetration enhancer
Ntxiv cov tshuaj tua kab mob (xws li cov kua tsib ntsev thiab cov surfactants) los txhawb kev nkag mus ntawm DSIP los ntawm txoj hnyuv mucosa. Kev nkag mus rau cov tshuaj muaj xws li sodium dodecyl sulfate (SDS), polysorbate 80, thiab lwm yam, thiab lawv cov concentrations yuav tsum tau tswj nyob rau hauv ib qho kev nyab xeeb kom tsis txhob mob plab hnyuv.
Cov txheej txheem tsim khoom ntawm DSIP capsules
Cov txheej txheem ntau lawm ntawmDSIP capsulessuav nrog plaub cov kauj ruam tseem ceeb: kev npaj cov khoom siv raw, kev npaj tsim, kev kuaj zoo, thiab ntim khoom:
Raw khoom npaj
DSIP raw cov ntaub ntawv: DSIP feem ntau yog muab nyob rau hauv daim ntawv ntawm khov- cov hmoov qhuav, thiab nws cov purity yuav tsum tau xyuas kom zoo dua los yog sib npaug li 98% (kuaj los ntawm HPLC), thiab nws yuav tsum tau raws li cov kev cai ntawm sterility thiab tsis muaj pyrogen.
Accessories: suav nrog cov ntaub ntawv nanocarrier (xws li liposome Cheebtsam), cov khoom siv txheej txheej, cov khoom siv nkag mus, cov tshuaj diluents (xws li lactose, microcrystalline cellulose), lubricants (xws li magnesium stearate), thiab lwm yam. Txhua tus excipients yuav tsum ua raws li cov qauv tshuaj qib.
Cov kuab tshuaj: Cov kuab tshuaj siv los ua kom yaj DSIP thiab cov khoom siv ntxiv (xws li dej txhaj tshuaj, ethanol) yuav tsum ua raws li cov cai ntawm pharmacopoeia thiab xyuas kom tsis muaj menyuam.
Kev npaj cov formulations
Kev npaj ntawm nanoparticles:
Kev npaj liposome: DSIP yog encapsulated nyob rau hauv lipid bilayers siv nyias zaj duab xis dispersion los yog rov qab theem evaporation txoj kev. Piv txwv li, phospholipids thiab cov roj cholesterol yog yaj hauv cov kuab tshuaj organic (xws li chloroform), evaporated los ua ib zaj duab xis nyias, thiab tom qab ntawd ntxiv rau DSIP aqueous tov rau hydration. Uniform liposomes yog npaj los ntawm ultrasound los yog extrusion txoj kev.
Kev npaj ntawm polymer nanoparticles: Txoj kev emulsion hnyav evaporation yog siv los yaj DSIP thiab polymers (xws li polylactic acid hydroxyacetic acid copolymer, PLGA) hauv cov kuab tshuaj organic. Tom qab emulsification, cov kuab tshuaj evaporates los tsim nanoparticles.
Kev npaj ntawm microspheres:
Extrusion dov txoj kev: Sib tov DSIP, diluent, thiab nplaum, extrude lub strip los ntawm ib tug extruder, thiab ces npaj pellets los ntawm ib tug dov mechanism.
Fluidized txaj txheej txheej: DSIP pellets muab tso rau hauv ib lub txaj fluidized thiab coated nrog enteric txheej tov los tsim enteric coated pellets.
Capsule filling: Muab cov nanoparticles npaj los yog microspheres nrog roj nplua nyeem thiab sau rau hauv cov tshuaj ntsiav tawv lossis mos. Cov txheej txheem filling yuav tsum tswj hwm ntawm ib puag ncig cov av noo thiab kub kom tsis txhob siv tshuaj nqus lossis degradation.
kev soj ntsuam zoo
Kev tshuaj xyuas qhov tshwm sim: Cov tshuaj ntsiav yuav tsum muaj qhov zoo nkauj, tsis muaj kab nrib pleb, tsis muaj xim, lossis khoom txawv teb chaws.
Kev txiav txim siab txog cov ntsiab lus: HPLC txoj kev siv los txiav txim siab cov ntsiab lus ntawm DSIP, kom ntseeg tau tias cov ntsiab lus ntawm DSIP hauv txhua lub tshuaj ntsiav ua tau raws li cov ntawv sau npe (xws li 100 μ g / capsule).
Kev kuaj kev puas tsuaj: Simulate lub plab hnyuv ib puag ncig (xws li hydrochloric acid tov nrog pH 1.2 thiab phosphate buffer tov nrog pH 6.8), txiav txim siab qhov kev sib cais ntawm DSIP, thiab xyuas kom meej tias nws tso tawm hauv txoj hnyuv.
Kev ntsuam xyuas kev ruaj ntseg: Muab cov tshuaj ntsiav nyob rau hauv kev ruaj ntseg ceev (xws li 40℃, 75% RH), tsis tu ncua kuaj cov ntsiab lus thiab kev sib cais ntawm DSIP, thiab ntsuas nws qhov ruaj khov.
Microbial limit test: Xyuas kom meej tias cov tshuaj ntsiav ua tau raws li cov qauv kev txwv microbial (xws li suav tag nrho cov kab mob<1000 CFU/g, mold and yeast<100 CFU/g).
ntim
Kev ntim khoom sab hauv: Siv cov ntawv txhuas PVC blister ntim los yog siab -cov fwj polyethylene ntom ntom los tiv thaiv cov tshuaj ntsiav los ntawm lub teeb thiab av noo.
Kev ntim khoom sab nraud: Ua los ntawm cov ntawv lossis cov thawv yas, luam tawm nrog cov npe khoom, cov lus qhia tshwj xeeb, tus lej batch, hnub tas sijhawm, thiab cov lus qhia siv.
Cia tej yam kev mob: DSIP capsules feem ntau yuav tsum tau muab cia rau hauv qhov chaw txias thiab qhuav (xws li 2-8 degree) kom lawv ruaj khov.
Kev Tswj Xyuas Zoo ntawm DSIP Capsules
Kev tswj xyuas zoo ntawm DSIP capsules yuav tsum ua raws li cov qauv tshuaj pharmacopoeia thiab cov kev cai cuam tshuam, feem ntau suav nrog cov hauv qab no:
Raw khoom zoo tswj
DSIP raw cov ntaub ntawv: Tus neeg muag khoom COA (Certificate of Analysis) yuav tsum tau muab, thiab lawv cov purity, noo noo, hnyav hlau, thiab microbial txwv yuav tsum tau kuaj los ntawm lawv tus kheej.
Cov ntaub ntawv pabcuam: Lawv cov yam ntxwv, kev txheeb xyuas, cov ntsiab lus, thiab kev txwv tsis pub dhau yuav tsum tau kuaj xyuas kom ua raws li cov qauv tshuaj qib.
Kev tswj xyuas cov kev npaj nruab nrab
Nanoparticles los yog microspheres: lawv cov particle loj tis, Zeta muaj peev xwm, encapsulation efficiency (rau nanoparticles), los yog roundness (rau microspheres) yuav tsum tau mus kuaj kom paub tseeb tias lawv ua tau raws li cov kev cai formulation.
Enteric txheej: Nws thickness, uniformity, thiab acid tsis kam (tsis muaj tshuaj tso tawm tsis pub dhau 2 teev nyob rau hauv hydrochloric acid tov nrog pH 1.2) yuav tsum tau kuaj.
Kev tswj cov khoom tiav tiav
Cov ntsiab lus tsis sib xws: Cov txheej txheem kev txiav txim siab cov ntsiab lus yog siv los xyuas kom meej tias qhov sib txawv ntawm DSIP cov ntsiab lus hauv txhua lub tshuaj ntsiav yog nyob rau hauv qhov kev teev tseg (xws li ± 10%).
Dissolution: Nws yog ib qho tsim nyog yuav tsum tau ua kom tau raws li cov qauv kev sib cais tau teev tseg hauv cov tshuaj pharmacopoeia (xws li Q tus nqi Ntau dua lossis sib npaug li 80%) kom ntseeg tau tias cov tshuaj bioavailability.
Stability: Cov ntaub ntawv ruaj ntseg ntev (xws li 24 lub hlis) yuav tsum tau ua pov thawj qhov kev ruaj ntseg zoo ntawm cov tshuaj ntsiav thaum khaws cia.
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